A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects

Phase 1

Completed

• Conditions: NASH - Nonalcoholic Steatohepatitis
• Interventions: Drug: EDP-305; Drug: Oral Contraceptive

• Registration Number: NCT03783897
• Lead Sponsor: Enanta Pharmaceuticals, Inc

Brief Summary

A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-27
• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-21
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-18
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• Females of childbearing potential, 18 to 45 years of age, inclusive. Follicle-stimulating hormone levels may be used to confirm premenopausal status, including females who have had a hysterectomy with ovaries still intact. Women who otherwise meet inclusion criteria and who have had tubal ligation, tubal occlusion, or bilateral salpingectomy will be allowed.

• Body mass index between 18.0 and 32.0 kg/m2, inclusive.

• In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Day -1 of the Lead-in Period

• Must not be pregnant or lactating, and must agree to use contraception

• Subjects must have documentation of normal results of up-to-date cervical cancer screening as specified in the American College of Obstetricians and Gynecologists guidelines:

  1. Women aged < 21 years: no documentation required
  2. Women aged 21 to 29: normal Pap smear test result within previous 3 years
  3. Women aged 30 to 45: normal Pap smear test result and negative high-risk human papilloma virus test within previous 5 years, OR normal Pap smear test result within previous 3 years If documented results are not available at Screening, the subject must provide documentation of normal results prior to Day -1 of the Lead-in Period.

• Able to comprehend and willing to sign an ICF.

• Willing and able to adhere to assessments, prohibitions, and restrictions as described in this protocol.

Exclusion Criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• Are pregnant, breastfeeding, or are planning to conceive during the study.
• Have been administered injectable contraceptives within 12 months prior to Day -1 of the Lead in Period, or had exposure to a hormonal intrauterine device or topical controlled delivery contraceptives (patch) within 3 months prior to Day -1 of the Lead-in Period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EDP-305 and Oral Contraceptive	EDP-305	-
EDP-305 and Oral Contraceptive	Oral Contraceptive	-

Primary Outcome Measures

Name	Time	Method
Cmax for OC with and without coadministration with EDP-305	Day 21 (cycle 2 and cycle 3)
Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305	Day 21 (cycle 2 and cycle 3)

Secondary Outcome Measures

Name	Time	Method
Safety measured by adverse events	Approximately 91 days
Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC	Days 14, 20-22 (cycle 3)
Cmax for EDP-305 when coadministration with OC	Days 14, 20-22 (cycle 3)

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States